So We Had Some Questions . . .
For the last few weeks, there’s been a rumor that HHS might actually respond to questions about the Institute of Medicine study. PANDORA urged HHS to address specific questions about the contract during phone calls and emails with HHS officials. The CFIDS Association also “contacted the CFSAC urging them to respond to a myriad of questions,” although they provide no other details about the context of that communication or the questions submitted.
In addition to the efforts of these two organizations, HHS has been buried in a deluge of organized petitions, letters signed by more than two hundred (combined) experts and advocates, and individual emails and letters.
The overall response to this deluge? A brick wall of silence. Since the announcement on September 23rd and the release of the Statement of Work on September 30th, HHS has officially said nothing about it. There have only been individual communications between IOM or HHS employees and advocates. Until now.
On November 15th, an email titled “FAQs Regarding the IOM Contract” went out via the CFSAC listserv. The email has been published in its entirety in a variety of places, but the CFIDS Association posted it first. I encourage you to read the entire document, but here are my standout raising-more-questions-than-answers-FAQ-moments.
TL;DR (Too Long, Didn’t Read?)
- The IOM study is aimed at the wrong target audience.
- They think they’re implementing a recommendation but they’re making it worse.
- They don’t explain why HHS can’t adopt the CCC.
- They ignore one of PANDORA’s most important questions.
- They contradict their own written descriptions of the NIH workshop.
But Who Is Answering?
Some people have questioned the authorship of the document (with good reason), specifically whether the CFSAC itself wrote or approved this document. Although the FAQ is not signed, I think we can safely assume that most CFSAC members had nothing to do with it.
How can I be so certain? Because if the CFSAC approved such a document – even if the vote was by email – it would be a violation of the Federal Advisory Committee Act which requires all meetings of the full Committee (electronic or otherwise) to be held in public. Given the Public Citizen smack down of the Committee for a similar violation earlier this year, I think that the CFSAC staff are more careful about these things.
The CFSAC listserv has become an all-purpose communication tool, in part because it is an effective way to get information out to the interested public. Announcements on behalf of other agencies, such as FDA meetings or CDC PCOCA calls, are routinely disseminated this way, although frequently days or even a week after we’ve already found out.
I think it is reasonable to assume that these answers were drafted by Dr. Nancy Lee and her staff, and sent out through the CFSAC listserv without even consulting the full committee. That is, of course, the pattern at the Office of Women’s Health. The entire IOM contract was conceived and developed by HHS staff, with only ONE member of the CFSAC consulted early in the process for input (and told to keep it confidential). I would be very surprised if something as sensitive (and rare) as public statements from HHS about the IOM contract were previewed or approved by the CFSAC itself. This is an HHS staff statement.
The Wrong Target Audience!
The first question of the FAQ is “Who is the target audience for the Institute of Medicine (IOM) study?” This was not one of the questions posed by PANDORA, and hasn’t really circulated in advocacy circles, so I’m not sure why this is the first question answered. But the answer is disturbing: the target audience is primary care providers because they don’t know how to diagnose ME/CFS, and patients have to see lots of doctors to finally get the diagnosis.
On the face of it, this seems reasonable. After all, my primary care doctor, and the first two doctors he referred me to, all failed to properly diagnose me.
But my primary care provider can’t diagnose cancer either. He might know I had a malignancy, but he would immediately refer me to an oncology specialist for diagnosis and treatment. My primary care doc can’t definitively diagnose artherosclerosis or rheumatoid arthritis or multiple sclerosis, either. He could suspect any of those diseases, maybe even screen me for them, but then my doctor would refer me to the cardiologist, rheumatologist, or neurologist best suited to diagnose the disease.
Saying that primary care physicians should be able to diagnose ME/CFS rests on two assumptions: that there is no medical specialty better suited to make the diagnosis and treat patients; and that ME/CFS is not so complex a disease that it requires care beyond what a general internist can provide. WRONG and WRONG.
I want primary care providers to know enough about ME/CFS to recognize when someone may need to be carefully evaluated for it, to know what tests might be helpful in screening, and to know which specialists are best suited to make the final diagnosis. A clinical case definition can help with this.
But I absolutely oppose the assumption that all we need is a quick checklist that any general nurse practitioner can use to label someone with ME/CFS and send them on their way to physical therapy. NO.
We Can’t Workshop Because . . . . ?
The October 2012 CFSAC recommendation states that HHS should convene a workshop of ME/CFS experts to reach consensus on a case definition beginning with the 2003 CCC. PANDORA asked why HHS could not convene the workshop and turned to the IOM instead.
In answering, HHS says it relies on professional societies and institutions like the IOM to develop guidelines and recommendations, and then disseminates those guidelines. HHS also says that making a clear distinction between clinical diagnostic criteria and a research definition will improve clinical care and research.
Never mind that the recommendation said that HHS should sponsor a meeting, not create a definition by itself. Never mind that the recommendation said that a single case definition for research, diagnosis and treatment was needed, not separate definitions. So not only has HHS not followed the recommendation, it has still not explained why.
But rest assured! The October 2012 recommendation has been addressed! The FAQ says, “as a direct result of the CFSAC recommendation, HHS’ contract with the IOM requires it to host public meetings and to include in the expert advisory committee ME/CFS experts (which could include members of CFSAC).” No, actually not. This contract only requires one public meeting, and we have no guarantee or information about meeting content.
And did you notice the last part of the sentence? As a direct result of the CFSAC recommendation, the IOM study will include ME/CFS experts which could include members of CFSAC. Several members of the CFSAC roster have been nominated to the IOM panel, including Dr. Levine, Dr. Marshall and Dr. Fletcher (all nominated by PANDORA).
In my opinion, even CFSAC members who are recognized experts in ME/CFS clinical care and research like Drs. Levine and Fletcher should not be on the panel. There has been so much rancor, division, controversy, and disagreement in CFSAC about the case definition recommendation, both publicly and privately, that I believe CFSAC members are biased on the issue. That’s just my personal opinion, but I will oppose the appointment of any current CFSAC member to the panel.
Why Not CCC?
PANDORA asked why HHS could not adopt the 2003 CCC, especially in light of the letter from the 50 experts to Secretary Sebelius. The answer? HHS can disseminate but not endorse guidelines made by nongovernmental groups and besides, the CCC is ten years old. I’m not buying it.
The Institute of Medicine is a nongovernmental group. That’s the POINT. Remember how I pointed out that the government cannot use IOM recommendations if it exerted influence over the development of them?
Yeah, so . . . . the government CAN and DOES both endorse and enact recommendations coming from nongovernmental organizations like IOM. Actually, they do it all the time and not just with IOM.
For example, Dr. Koh recently said that HHS was implementing recommendations from an IOM report on epilepsy that was co-sponsored by federal agencies and non-profit groups. The CDC recommends the American College of Rheumatology’s criteria for diagnosing fibromyalgia, and refers people to the Lyme disease treatment guidelines from the Infectious Disease Society of America.
In all three cases, HHS is endorsing recommendations and guidelines created by nongovernmental groups, not merely disseminating them. I’m sure HHS has its reasons for refusing to adopt the CCC, but those reasons are not the ones offered in this FAQ.
I Could Drive a Truck Through These Holes (if I could still drive)
One of PANDORA’s questions was, “Can the IoM contract be canceled? If not, why not?” The FAQ does not answer the question.
Instead, the FAQ answers a different question: “If the IOM contract is cancelled, will the contract funds go to ME/CFS research?” HHS says, “There is no way for HHS to recover or repurpose these funds.” Fine, but that’s not what we need to know.
First, where did the funding come from? Did it actually come from NIH’s research budget? I assumed the answer to that was no, and that there was never a chance that the money could be used for research regardless of what happened to the IOM contract.
Second, IOM says that HHS and the Social Security Administration funded the study. This FAQ says, “Almost all of the agencies that have efforts involving ME/CFS contributed Fiscal Year (FY) 2013 funds to this study.” Presumably this means HHS agencies, but it still does not tell us which agencies and how much they contributed. I would like to see the full breakdown, and I’m hoping that one of my FOIA requests will provide it.
Another question from PANDORA was completely ignored in the FAQ: “[W]hat guaranteed [sic] can you give that [IOM] won’t come back with something more broad, and thus more harmful, than Fukuda?”
THIS is the question we all want the answer to. In fact, it is arguably the MOST IMPORTANT question of all.
Answer?
*insert sound of crickets chirping here*
The Shifting Sands of NIH
From the very beginning, advocates have been concerned about how multiple case definition efforts would be coordinated. At first, we were worried about the CDC multi-site study and the scope/coordination of the NIH Evidence-based Methodology Workshop (EbMW).
Our concerns were heightened after the announcement of the IOM effort, and alarm bells went off in my head when the Statement of Work said that IOM should coordinate with EbMW “to minimize overlap and maximize synergy. . . [and] assure that relevant information is shared and that key messages are coordinated.”
The FAQ attempts to address this by quoting an unnamed person at NIH:
The expected outcome from the Evidence-based Methodology Workshop for ME/CFS is to identify research gaps in ME/CFS, identify methodological and scientific weaknesses in the ME/CFS field, suggest research needs that will advance the ME/CFS field, and move the field forward through an unbiased, evidence-based assessment of this complex public health issue.
Do you notice what is MISSING from this description of the EbMW? There is nothing in there about a research case definition.
Which is funny, actually, because in a statement on the CFSAC listserv on September 3rd, HHS said “NIH will be convening an Evidence-based Methodology Workshop, which would address the issue of case definitions appropriate for ME/CFS research“. (emphasis added) The same description appeared in the CFSAC listserv announcement on September 23rd.
That phrase – “address the issue of case definitions appropriate for ME/CFS research” – seems to have originated from Dr. Koh’s written statement to the CFSAC in May 2013 describing the EbMW.
Despite all these statements in writing that the EbMW will address the issue of case definitions for ME/CFS research, this FAQ now (presumably) quotes someone (presumably) at NIH as describing the EbMW in a way that does not even mention the case definitions appropriate for ME/CFS research.
Any number of possible explanations come to mind: the EbMW purpose and approach has shifted; Koh’s written statements about the EbMW were wrong; this FAQ is wrong; different people at HHS have different understandings of the EbMW, some or all of which are wrong; this is an attempt to mislead the public; or no one has any idea what they’re doing.
I Have Ninety-Nine Questions, And This Answers None of Them
I am becoming accustomed to written statements from HHS that add to the questions I have, rather than actually answering any of them. This FAQ document is just another example. According to the draft agenda for the CFSAC meeting on December 10th, Dr. Lee will discuss the IOM study for 30 minutes. The agenda does not indicate whether the Committee members will be permitted to ask questions or comment.
One can only hope that Dr. Lee’s presentation will clear up the confusion and address the long list of concerns about the contract. This FAQ has not succeeded in doing so.
Denise Lopez-Majano assisted with research for this post.
Understanding the CFS Advisory Committee is not limited to what happens in the meetings. The paths that lead members to their seats at the table are very important too. Regular readers of this blog know that I’ve tracked the nomination sources for all the members. I now have new information about how Dr. Gary Kaplan was nominated to the Committee, and it potentially changes the full context of the Committee balance. In fact, I can now show you a very disturbing trend in which nominations seem to be the most successful under Dr. Nancy Lee.
Which Disease Is HHS Studying?
I am very pleased to share space today with Mary Dimmock. She has written this guest post about which disease HHS has asked IOM to define. Her conclusion will probably increase any concerns you have about the IOM study. Mary has given us all permission to repost this article.
Mary Dimmock
HHS recently issued an FAQ about the IOM contract. As Jennie Spotila, Erica Verillo, Lois Ventura and Jeannette Burmeister pointed out, the FAQ falls far short of providing useful answers, is misleading and leaves critical questions unanswered.
Like the fundamental question: “What disease is HHS developing definitions for – ME or the diverse conditions that meet the overly broad “CFS” criteria?
I recently asked that question of both IOM’s Kate Meck and HHS’ Dr. Nancy Lee. From their answers, which I summarized below, the only possible conclusion is that the IOM study is intended to establish diagnostic criteria for the diverse conditions that meet the overly broad “CFS” criteria and that ME will be treated as a subgroup.
All of us, patients, advocates and experts alike, must reject this as completely unacceptable. We must call on HHS to acknowledge that ME is not part of the overly broad CFS. We must continue to call on HHS to adopt the Canadian Consensus Criteria.
We all know the problem. ME, the neurological disease characterized by post-exertional malaise, cognitive issues and immunological dysfunction has been buried inside of “CFS”, a diverse collection of medically unexplained fatiguing conditions. Numerous authors, especially Dr. Jason of DePaul, have reported extensively on the serious research and clinical problems caused by these overly broad CFS definitions, definitions that lump biologically unrelated conditions together. Dr. Bruce Carruthers summed it up simply, “There is a poignant need to untangle the web of confusion caused by mixing diverse and often overly inclusive patient populations in one heterogeneous, multi-rubric pot called ‘chronic fatigue syndrome.”
Having rejected the Canadian Consensus Criteria as unacceptable, HHS is conducting three separate initiatives to develop its own criteria. But what does HHS intend to do about the “web of confusion” that ha been created by “CFS”? What disease will these new criteria describe?
The ME/CFS IOM Statement of Work is ambiguous on this point as it uses the same jumbled, non-specific disease labels that have gotten us into this mess to begin with. The SOW states:
I asked both Kate Meck at the IOM and Dr. Lee, the designated federal official for the CFS Advisory Committee (CFSAC) to clarify what “scope of disease” had been specified in the IOM contract. Has the IOM been contracted to develop clinical criteria specifically for ME? Or has IOM been contracted to develop clinical criteria for the range of unrelated fatiguing conditions that meet the “CFS” criteria? I asked Dr. Maier of NIH and Dr. Beth Collins-Sharp of AHRQ a similar question on the NIH Evidence Based Methodology Workshop process and am waiting on a promised response.
Here’s a summary of the responses I received from Dr. Lee of HHS and Kate Meck of the IOM:
In a follow-up email, Dr. Lee confirmed the above statements but also reiterated an earlier point she had made that the IOM task list specifies that the “committee will also distinguish between disease subgroups”. She also said that in order for the target audience – defined as the primary care physicians – to effectively use the resultant guidance, “it is important to start a bit broad and then have criteria which distinguishes between subgroups.”
These answers are profoundly disturbing.
First, the statement that the scope of disease has not yet been defined is frankly hard to believe. This is a million dollar contract and panel selection is due to be announced soon. How can such a critical issue as the scope of disease to be covered by the new criteria be undecided at this point? If it really is undecided, who will decide and how? What criteria have been used to select the panel? And will that panel still be the appropriate one once a decision is reached on what disease or diseases the new criteria will cover?
But the statements about subgroups and spectrum of illnesses are much more disturbing.
Yes, ME is a complex disease that needs to be broken down into legitimate subgroups in order to better understand the disease and the treatment options. Perhaps those subgroups are based on whether onset is sudden or not, the level of severity of the disease or the nature of the immune profile and viral load. But let’s be realistic. What is the likelihood that the panel selected for the IOM study is going to be able to identify proper subgroups of ME itself when our experts are still working through that? Or when the evidence base lacks the ME specific studies – studies done with proper ME definitions – that would be needed to substantiate ME subgroups?
At the same time, we have an agency with a long-term commitment to studying medically unexplained chronic fatigue as the single clinical entity, “CFS”. We have an agency that has taken the position that Oxford, Fukuda and the Canadian criteria all describe the same set of patients for whom one set of clinical guidance is appropriate. We have an agency that questions the scientific evidence surrounding even post-exertional malaise and its measurement while simultaneously rejecting the Canadian Consensus Criteria because it does “not account for scientific evidence developed since 2003.” We have the CDC’s Dr. Unger, rhetorically asking at the May 2013 CFSAC “If a patient doesn’t have [PEM], wouldn’t you still manage them as a “CFS” patient?” And we have the IOM adopting the same overly broad view of CFS as HHS in recent IOM publications on Gulf War Illness.
Now we have Dr. Lee stating that the target audience of the new criteria is the primary care physicians and that they need criteria that start broader and then distinguish between subgroups. What about the patients who desperately need criteria that accurately reflect their disease?
What are we to conclude from all this? HHS has not committed to criteria specific to ME. HHS is not talking about the proper subgroups of ME that we all envision. HHS intends the IOM study to define criteria for the broader set of CFS conditions, with ME characterized as a subgroup. Or worse, ME becomes a subgroup of the even broader chronic multisymptom illness (CMI).
Either way, this will be a disaster that will degrade ME research and worsen the abysmal clinical care and stigma that ME patients receive today. This is the nightmare scenario that we all fear.
If HHS truly wants to reverse the chaos and the grievous harm to patients caused by years of sloppy definitions, it will first and foremost declare that ME, the disease described by the Canadian Consensus Criteria, is not the same disease as the overly broad “CFS” and should not be considered as either a subgroup of CFS or part of a spectrum of CFS diseases.
And if HHS cares not only about primary care physicians but also about the ME patients that they treat, it will acknowledge the harm done to patients by its clinical guidelines as reported at a recent Mount Sinai conference. CDC will immediately highlight PEM as a hallmark symptom of ME, will provide “black box warnings” about the adverse effects of exercise on ME patients and will point clinicians to the Canadian Consensus Criteria and the IACFS/ME primer.
Beyond that, HHS needs to immediately require that the Canadian Consensus Criteria be used in every study funded by NIH, even if it is used in parallel with Fukuda as an interim step.
Patients, advocates and experts alike must demand and accept no less, especially in the context of the IOM study and the NIH Evidence Based Methodology process.